Efficacy and Safety of Intravenous Ganaxolone in Status Epilepticus

Summary

Status epilepticus is a serious condition that requires immediate treatment to stop the seizures and prevent permanent brain damage. The purpose of this study is to determine whether an investigational drug called ganaxolone can stop or decrease seizure activity in participants who have SE and whether it is safe when given to participants who are on other anti-seizure medications. Participants will be randomly assigned to receive either ganaxolone or placebo. Ganaxolone will be added on to usual for SE.


Inclusion Criteria

  • Participant, participant's parent, guardian, or LAR must provide signature of informed consent/assent, and once capable (per institution guidelines), there must be documentation of consent/assent by the participant demonstrating they are willing and aware of the investigational nature of the study and related procedures
  • Male or females 12 years of age and older at the time of the first dose of IP
  • Convulsive or nonconvulsive SE with seizure burden warranting imminent progression to IV anesthesia for seizure control. Ictal patterns and burden defined below.
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

A double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of intravenous ganaxolone in status epilepticus

Details
Disease Type/Condition

Other

Principal Investigator

Toossi, Shahed

Co-Investigators

Chrystal Reed, Jeffrey Chung, Lisa Bateman

Age Group

Adult

Phase

III

IRB Number

STUDY00001403

ClinicalTrials.gov ID

NCT04391569

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Other

Principal Investigator

Toossi, Shahed

Age Group

Adult

Phase

III

IRB Number

1042-SE-3003

ClinicalTrials.gov ID

NCT04391569

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?